The present invention relates to improved treatment of dandruff, itch or other skin disorders involving excessive or abnormal shedding of dead epidermal cells from the scalp. Dandruff is a condition involving an increased rate of shedding of scales from the scalp wherein the scales are shed in large clumps. The scales appear dry and white or grey and are usually seen in small round patches on the crown of the head. In some cases the patches may cover the entire scalp. Itching is an occasional complaint; however, the primary concern is the unsightly appearance of the scales. In seborrheic dermatitis, there is a greater increase in the shedding of skin than with dandruff. This condition is marked by inflammation and increased itching. In psoriasis, there is chronic inflammation characterized by well-defined pink or red lesions covered with silvery scales.
It is known in treatment of the above disorders that increased cleaning and/or topical application of certain agents reduces scaling and inflammation.
Anti-inflammatory agents have long been used for the treatment of various skin and scalp disorders such as psoriasis, seborrhea, dermatitis, dandruff, and the like. However, these compounds have generally been available in non-rinse vehicles which contain oils or emulsions which would give the hair a soiled appearance.
Adrenal corticosteroids, and the synthetic analogues thereof, are some of the most useful pharmaceutical actives known in the art. These compounds have the capacity to prevent the development of, or suppress existing, localized heat, redness, tenderness and swelling which characterizes any inflammation of skin or mucous membrane. The utility of these compounds is shown in a clinical setting by the fact that cortiocosteroids inhibit this inflammatory response whether the inciting cause or agent is radiant, mechanical, chemical, infectious or immunological. Since the first recognition of the potent anti-inflammatory properties of these compounds in 1949, their therapeutic uses have increased dramatically. The unique biochemical, pharmacologic and physiologic properties of cortiocosteroids make them extremely useful in the topical treatment of inflammatory conditions. Several patent references disclose representative compositions.
U.S. Pat. No. 4,343,798, Fawzi, issued Aug. 10, 1982, describes topical antimicrobial/anti-inflammatory compositions containing C.sub.5 -C.sub.12 fatty acids in combination with cortiocosteroids.
U.S. Pat. No. 3,934,013, Poulsen, issued Jan. 20, 1976, describes topical pharmaceutical compositions containing at least two cortiocosteroids, propylene glycol, a fatty alcohol and water. The patentee describes the "fatty alcohol ingredient" as any fatty alcohol having from 16-24 carbon atoms and, preferably, as a saturated, monohydric primary alcohol such as cetyl alcohol, or stearyl alcohol.
U.S. Pat. No. 4,289,764, Yarrow, et al, issued Sept. 15, 1981, describes topical pharmaceutical compositions with increased shelf stability. These compositions comprise a steroid, 15-50% by weight propylene glycol and are buffered to a pH of 2.7-3.3. The specification describes the desirability of thickening the propylene glycol (due to its low viscosity) with a compound selected from long-chain paraffins, fatty alcohols, and waxes, including cetyl stearyl alcohol, white soft paraffin and liquid paraffin.
U.S. Pat. No. 4,070,462, Ecker, issued Feb. 24, 1978, discloses a topical vehicle which includes (i) 5-15% 1,2-propanediol, 2,3-butanediol or 2-methyl-2,4, propanediol; (ii) 1-3% propylene glycol monostearate; and (iii) petrolatums and waxes to 100%.
The compositions described in these references are all left on the skin. They therefore do not suggest the advantages and the problems associated with a rinse-off product, such as a shampoo.
U.S. Pat. No. 3,881,000, Friedmann et al, discloses bis(phosphoylated)anthralin compounds for use in the treatment of psoriasis. Anti-inflammatories such as cortisone, hydrocortisone, hydrocortisone acetate, and prednisolone are disclosed as auxiliary agents in lotions, ointments, and shampoos of the invention.
While a shampoo composition is disclosed in Friedmann, there is no suggestion that only water-insoluble, particulate anti-inflammatory would provide deposition in effective therapeutic amounts. It is desirable therefore to provide shampoo such as lotions containing particulate anti-inflammatories.
Lotion shampoos, both antidandruff as well as nondandruff types, are disclosed in the art. U.S. Pat. No. 3,917,817, Vanlerberghe et al., issued Nov. 5, 1975, discloses a shampoo composition containing a piperazine based cationic polymer, 10% sodium alkyl sulfate, 4% lauryl monoethanolamide and 3% glycol distearate. U.S. Pat. No. 4,013,787, Vanlerberghe et al., issued Mar. 22, 1977, discloses a similar composition. Japanese Application, with Open for Public Inspection No. 60810, May 19, 1977 (Lion Fat & Oil), discloses shampoos containing 5% to 50% of an anionic surfactant, 1% to 10% of a fatty acid diethanol amide, 0.1% to 10% of an insoluble fine powder, and 1% to 10% of an ethyleneglycol ester. U.S. Pat. No. 4,470,982, Winkler, issued Sept. 11, 1984, discloses lotion antidandruff shampoos containing ethyleneglycol esters and an antidandruff agent.
While these references, all of which are incorporated herein by reference, disclose compositions which contain components similar to those present in the compositions of the present invention, they do not suggest the advantages found by the present inventor for the compositions disclosed herein.
It is an object of the present invention to provide shampoo compositions which provide deposition of an effective amount of a water-insoluble particulate anti-inflammatory agent.
It is a further object of the present invention to provide a consumer acceptable suspension system capable of suspending an effective amount of the anti-inflammatory in a lotion shampoo.
It is a further object of the present invention to provide shampoo compositions containing safe and effective amounts of a water-insoluble, particulate anti-inflammatory and a second anti-dandruff agent.
These and other objects will become more apparent from the detailed description below.